Diabetes Clinical Trial
— DREAMOfficial title:
Health Beliefs, Glycemic Control, and Preventing Cognitive Decline in African Americans With Diabetes and Mild Cognitive Impairment: A Randomized Clinical Trial
This double-masked, 2-year, single-site, phase II RCT will test the efficacy of DREAM (Diabetes Regulation for Eye Sight and Memory to prevent cognitive decline in African Americans (AAs) with amnestic multiple domain mild cognitive impairment (MCI) and poorly controlled diabetes (i.e., hemoglobin A1c [HbA1c] level ≥ 7.5%). Participants will be randomized to DREAM [11 home-based treatment sessions with a community health worker (CHW), and 4 telehealth visits with a Diabetes Nurse Educator over 2 years] or Enhanced Usual Care (EUC), which is usual care enhanced with home-based diabetes education. The primary outcome is decline in verbal memory over 2 years. Follow-up data will be collected at 6, 12, 18, and 24 months. In addition, participants will have ophthalmology assessments (at Wills) at baseline, 12 and 24 months to determine whether retinal Vessel Area Density, and/or Retinal Nerve Fiber Layer thickness mediate DREAM's treatment effect.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 31, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - African American race - Age = 65 years - Type 2 DM - Duration of DM = 1 year - HbA1c = 7.5 - Amnestic multiple-domain MCI by NIA-AA criteria - Able to provide written informed consent Exclusion Criteria: - Dementia - Excluded medical conditions - Life expectancy less than two years in the opinion of the PCP - Psychiatric disorders - Cannot provide written consent |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Glycemic Control | Hemoglobin A1c (HbA1c) | 24 months | |
Other | Retinal Vessel Area Density Layer thickness mediates treatment effects; | Retinal Vessel Area Density | 24 months | |
Other | Retinal Nerve Fiber Layer Thickness Layer thickness mediates treatment effects; | Retinal Nerve Fiber Layer Thickness | 24 months | |
Other | Dementia | Incidence of dementia based on an adjudication panel | 24 months | |
Primary | Decline in Verbal Memory | Scores on the Hopkins Verbal Learning Test total recall (HVLT) | 24 months |
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